Erlotinib and Sequential Positron Emission Tomography (PET) in Advanced Non Small Cell Lung Cancer (NSCLC) (ERLOPET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Lung Cancer Group Cologne.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Lung Cancer Group Cologne
ClinicalTrials.gov Identifier:
NCT00568841
First received: December 5, 2007
Last updated: September 16, 2009
Last verified: September 2009
  Purpose

This is a Phase-II Study to evaluate the accuracy of Fluorodeoxyglucose-/Fluorothymidine-Positron Emission Tomography (FDG-/FLT-PET) analyses for early prediction of non-progression in patients with non-small-cell lung cancer (NSCLC) treated with Erlotinib.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: erlotinib
Procedure: FDG-/FLT-PET
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase-II Clinical Trial to Evaluate the Accuracy of FDG-/FLT-PET for Early Prediction of Non-progression in Patients With Advanced NSCLC Treated With Erlotinib and to Associate PET Findings With Molecular Markers

Resource links provided by NLM:


Further study details as provided by Lung Cancer Group Cologne:

Primary Outcome Measures:
  • To evaluate the accuracy of FDG-/FLT-PET analyses for early prediction of non-progression in patients with NSCLC treated with Erlotinib [ Time Frame: 34 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To identify PET characteristics for progression, response and stable disease; To identify EGFR and KRAS sequence characteristics for clinical response and stable disease; Safety; Response rates; One-year FFTF; One-year OS; Median overall survival time [ Time Frame: 34 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: October 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: erlotinib
erlotinib p.o. (by mouth), 150 mg once daily for week 1-6 (day 1-42)
Procedure: FDG-/FLT-PET

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • ≥ 18 years of age
  • Untreated non-small-cell lung cancer stage IIIB/IV
  • Life expectancy > 3 months
  • Performance status ECOG 0-2

Exclusion Criteria:

  • Concurrent systemic immune therapy, chemotherapy or therapy with any anticancer drug not indicated in the study protocol
  • Any investigational agent(s) within 4 weeks prior to study entry
  • Previous administration of any EGFR-targeted therapy (antibodies, small molecules and others)
  • Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568841

Locations
Germany
Center for Integrated Oncology, University Hospital Cologne, Department I of Internal Medicine, Kerpenerstr.62
Cologne, Germany, 50924
Sponsors and Collaborators
Lung Cancer Group Cologne
Investigators
Principal Investigator: Juergen Wolf, Prof., Dr. University Cologne, Lung Cancer Group Cologne
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Juergen Wolf, University Cologne
ClinicalTrials.gov Identifier: NCT00568841     History of Changes
Other Study ID Numbers: 2005-005393-73, 06159
Study First Received: December 5, 2007
Last Updated: September 16, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Lung Cancer Group Cologne:
advanced Non-Small-Cell Lung Cancer
erlotinib
FDG-PET
FLT-PET

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014